跳至主要内容
临床试验/NCT05423912
NCT05423912
已完成
不适用

Keeping on Course: A Communication-Focused Psychoeducation Program for Dyads Coping With Mild Cognitive Impairment

Emory University1 个研究点 分布在 1 个国家目标入组 29 人2023年2月8日

概览

阶段
不适用
干预措施
Keeping on Course Program
疾病 / 适应症
Mild Cognitive Impairment
发起方
Emory University
入组人数
29
试验地点
1
主要终点
Intervention Appropriateness Measure (IAM) Score
状态
已完成
最后更新
3个月前

概览

简要总结

The goal of Keeping on Course is to develop and test a psychoeducation program to provide dyads facing mild cognitive impairment (MCI) with communication skills and strategies that will establish or restore a sense of agency as they cope with MCI.

详细描述

Up to 21% of older adults exhibit symptoms of mild cognitive impairment (MCI), a term used to describe a compilation of cognitive and behavioral symptoms that approach but don't meet the threshold for a dementia diagnosis. Noticeably characterized by losses in executive function and memory that can affect critical life domains like employment, housing, health care, and finances, it is also a life condition of considerable indeterminacy both for the person living with the condition and for care partners. While many individuals experience worsened symptoms leading to an Alzheimer's disease (AD) diagnosis within five years, MCI can be caused by a variety of disease processes making disease trajectory and prognosis vague and uncertain. For most diagnosed with MCI, the experience is shared with another, typically a spouse or partner. In many cases, other members of the family, including fictive kin, are part of the team providing care and support - not only to the person living with MCI but to the principal caregiver, as well. For the dyad and both parties in an MCI couple individually, the period following an MCI diagnosis is often one of extended emotional turbulence and ambiguity. Care partner dyads coping with MCI face changes in role identity resulting in significant consequences for relationships, and the turbulence extends beyond the dyad to the larger extended family. It is unclear what the future might hold or how pervasively established patterns of living will be altered. The foundations of shared expectations and of trustworthy methods of planning, communication, and decision-making are disrupted in unpredictable ways. Emotional adjustment to MCI, unique for each dyad, has implications for subsequent family coping, psychological stress, physical fatigue, social isolation, decision-making, financial well-being, and more. While MCI psychoeducation programs exist, they almost always target the person with MCI and not the patient-care partner dyad. Communication patterns between patients and care partners in oncology and HIV/AIDS settings are shown to influence the coping and care outcomes of dyads. With similar communication issues noted in MCI dyads, the goal of this pilot project is to develop and test the feasibility and preliminary efficacy and evaluate acceptability of a group program, Keeping on Course, to provide couples facing MCI with communication skills and interpersonal strategies that will establish or restore a sense of agency and emotional well-being as they navigate this period of transition and uncertainty. This study uses a one-arm, pre/post design to assess the acceptability, feasibility, and preliminary efficacy in 4 cohorts of 6 MCI dyads each (for a total of 48 individuals) to take part in a trial of the Keeping on Course program. Participants meet in virtual intervention group meetings over the course of 6 consecutive weeks. Participants are asked to take part in structured quantitative interviews prior to the intervention and then 4 and 8 weeks post-intervention.

注册库
clinicaltrials.gov
开始日期
2023年2月8日
结束日期
2025年12月8日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Kenneth Hepburn

Professor

Emory University

入排标准

入选标准

  • Either a person with MCI, defined as a score of 23-27 on the Mini-Mental State Examination (MMSE) or a score of 19-25 on the Montreal Cognitive Assessment (MoCA), or an MCI care partner
  • Can read, speak, and understand English
  • Have internet connectivity and a separate zoom-enabled device for each dyad member
  • Dyads must live together, as this will provide sufficient opportunity for intervention homework and communication practice activities

排除标准

  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
  • Individuals who are not able to clearly understand and speak English
  • Those living with MCI will need to successfully complete a capacity to consent survey to be included in the study

研究组 & 干预措施

Keeping on Course Program for Persons with Mild Cognitive Impairment (MCI)

Persons with MCI participating in the Keeping on Course program.

干预措施: Keeping on Course Program

Keeping on Course Program for Care Partners of MCI Participants

Care partners participating in the Keeping on Course program with the MCI participant they care for.

干预措施: Keeping on Course Program

结局指标

主要结局

Intervention Appropriateness Measure (IAM) Score

时间窗: 4 weeks post-program, 8 weeks post-program

Appropriateness of the Keeping on Course program is assessed with three items from the Intervention Appropriateness Measure (IAM). Items are scored on a 5-point scale where "completely disagree" = 1 and "completely agree" = 5. The total score is the average score of all items and ranges from 1 to 5. Higher scores indicate greater appropriateness of the intervention.

Feasibility of Intervention Measure (FIM) Score

时间窗: 4 weeks post-program, 8 weeks post-program

Feasibility of the Keeping on Course program is assessed with three items from the Feasibility of Intervention Measure (FIM). Items are scored on a 5-point scale where "completely disagree" = 1 and "completely agree" = 5. The total score is the average score of all items and ranges from 1 to 5. Higher scores indicate greater feasibility of the intervention.

Attendance

时间窗: Up to Week 6

Feasibility of the intervention is assessed with the number of sessions attended.

Completion of Homework Assignments

时间窗: Up to Week 6

Feasibility of the intervention is assessed with the number of homework assignments completed.

Group Participation

时间窗: Up to Week 6

Feasibility of the intervention is assessed with the number of participants engaging in group activities.

Percent of Participants Completing Surveys

时间窗: Baseline, 4 weeks post-program, 8 weeks post-program

Acceptability of measurements used to understand decision-making in dyads coping with MCI is assessed as the completion rates of each of four instruments. An instrument is considered acceptable if there is a 90% completion rate for an instrument.

Acceptability of Intervention Measure (AIM) Score

时间窗: 4 weeks post-program, 8 weeks post-program

Acceptability, appropriateness, and feasibility of the Keeping on Course program are assessed with three items from the Acceptability of Intervention Measure (AIM). Items are scored on a 5-point scale where "completely disagree" = 1 and "completely agree" = 5. The total score is the average score of all items and ranges from 1 to 5. Higher scores indicate greater acceptability of the intervention.

Awareness, Courage, and Responsiveness Scale Score

时间窗: 4 weeks post-program, 8 weeks post-program

The Awareness, Courage, and Responsiveness Scale asks 24 questions to measure awareness of others, self-awareness, courage, and responsiveness towards others. Responses to survey items are given on a 7-point scale where "never true" = 1 and "always true" = 7. The total score ranges from 24 to 168. Higher scores indicate greater expression of interpersonal dynamics of being aware, courageous in uncomfortable situations, and being responsive to the needs of others.

次要结局

  • Midlife Development Inventory (MIDI) Sense of Control Scale(Baseline, 4 weeks post-program, 8 weeks post-program)
  • Decision-Making Involvement Measure(Baseline, 4 weeks post-program, 8 weeks post-program)
  • Decision-Making Involvement Measure - Overall Satisfaction(Baseline, 4 weeks post-program, 8 weeks post-program)
  • Decision-Making Involvement Scale(Baseline, 4 weeks post-program, 8 weeks post-program)
  • Perceived Stress Scale (PSS-14) Score Among Care Partners(Baseline, 4 weeks post-program, 8 weeks post-program)

研究点 (1)

Loading locations...

相似试验